MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC UV ABSORBING IOL; INTRAOCULAR LENS

Model Number CC60WF

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A clinical director reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens was placed in the patient¿s eye, it was then discovered that there was a scratch on the lens.The lens was then removed from the patient.All of these events took place on the same day.Additional information was received stating patient's symptoms were resolved.There was no patient harm.

Manufacturer Narrative

The account indicated the use of a qualified associated cartridge and viscoelastic.The handpiece indicated is not qualified for the lens/cartridge combination used.The company lens model is only qualified for use with the company handpiece.The root cause is most likely related to a failure to follow the ifu (instructions for use).The account used an unqualified lens/cartridge/viscoelastic combination.Company foldable intraocular lenses are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the intraocular lens and potential complications during the implantation process.The product has not been received to evaluate.File will be reopened when product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16069119
• MDR Text Key: 308268557
• Report Number: 1119421-2022-02769
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CC60WF
• Device Lot Number: 15431483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LENS LOADING FORCEPS; MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR; PROVISC
• Patient Age: 60 YR
• Patient Sex: Male